一加一大于二默沙东联手Syndax开发突破性肿瘤药物联合疗法

2015年4月1日讯/生物谷BIOON/--最近，默沙东公司宣布将和位于美国麻省沃尔瑟姆的小型生物医药公司Syndax进行合作开发肿瘤联合疗法。能被制药巨头默沙东选为合作伙伴，Syndax公司可并不是浪得虚名。事实上，Syndax公司是FDA自2013年开始进行突破性药物认证以来第一批获此殊荣的公司。公司开发的entinostat是一种脱乙酰化酶抑制剂药物，目前正处于治疗抗药性绝经期妇女乳腺癌相关的临床三期研究。
FDA此前已经表示如果entinostat能够在无进展生存期方面实现突破，FDA将对其采取有限审批的措施。这也可见FDA对entinostat的期望之深。
此次默沙东希望结合公司新近上市的PD-1药物Keytruda和entinostat联合治疗非细小细胞肺癌和黑色素瘤。这一协议也被认为是公司大力推广Keytruda计划的一部分。
随着肿瘤免疫疗法市场的持续火爆，PD-1药物领域的研究更加趋于白热化。默沙东、百时美施贵宝、阿斯利康、罗氏均在推进各自的临床项目，同时广泛合作深度挖掘各自免疫疗法的临床潜力。
就在近日，百时美与BavarianNordic签署高达10亿美元协议，合作开发癌症免疫鸡尾酒。就在不久之前，默沙东还与日本药企卫材（Eisai）宣布了一项战略合作开展多个临床试验，评估其PD-1免疫疗法Keytruda（pembrolizumab）与卫材肿瘤学药物Lenvima（lenvatinib）和Halaven（eribulin）组合疗法的疗效和安全性。（相关阅读：默沙东牵手卫材深度挖掘PD-1免疫疗法Keytruda临床潜力）双方已计划开展的研究包括：一项Ib/II研究将调查Keytruda+Lenvima组合疗法用于特定实体瘤；一项Ib/II研究评估Keytruda+Halaven用于三阴乳腺癌（TNBC）。
详细英文报道：
Aretwobreakthroughcancerdrugsbetterthanone?PharmagiantMerck($MRK)andWaltham,MA-basedSyndaxplantofindoutinaPhaseIb/IIstudymatchingthetinybiotechsentinostatwithKeytruda,Mercksbiganti-PD-1therapy,foreithernon-smallcelllungcancerormelanoma.Investigatorsplantostartrecruitingforthestudyinthesecondhalfofthisyear.
Syndaxwasoneofthechosenfewamongthelittlebiotechstogainabreakthroughdrugdesignationforacancerdrug,joiningthefirstwaveofBTDsbackin2013foranexperimentalhistonedeacetylase(HDAC)inhibitornowinPhaseIIItestingintreatment-resistantpostmenopausalwomenwithmetastaticER-positivebreastcancer.TheFDAissuedthedesignation--whichoffersapotentiallyshorterpathtoanapproval--afterreviewingpromisingprogression-freesurvivalandoverallsurvivaldatarackedupinPhaseII.
Thislatestimmuno-oncologycollaborationfollowsalengthystringofpactsinkedbyMerck,whichseesitsPD-1drugasanaturalcomboforawiderangeoftargeteddrugs.Keytrudaworksbydismantlinganaturalcloakingdevicecancercellsusetostayhiddenfromtheimmunesystem.AndMerckhasbeenclosebehindBristol-Myers,theleaderinthefieldwithOpdivo,anIOdrugrecentlyapprovedtotreatlungcancer.
SyndaxtriedtocapitalizeonitsBTDwinattheFDAwithanIPOlastyear,butlaterthrewinthetowelontheofferingandinkeda$100millionlicensingdealwithKyowaHakkoKirininJanuary,whichincludeda$25millionupfrontpaymentforrightstotheJapaneseandKoreanmarkets.SyndaxCEOArleneMorristoldXconomysBenFiedlerafewweeksagothatthebiotechdecidedtosteerclearoftheIPOmarketfornowafterdeterminingthedrugspotentialinanimmuno-oncologycombo,hintingabouttheMerckdealthenintheworks.
Butnooneisofferinguptelltalefinancialdetails,includingwhospayingforthenewstudy,whichcouldpavethewaytoapivotallate-stagetrial.
Syndaxisa2007Fierce15company.ThebiotechhasbeenfinancedbyDomainAssociates,whichbroughtintheirRussianpartnersatRusnanoMedInvestonasyndicatethatalsoincludesMPMCapitalandForwardVentures.DomainfoundedthecompanywithtechnologydevelopedattheSalkInstitute
"Thebroadbaseofclinicaldatainvolvingouranti-PD-1therapy,Keytruda,continuestoprovideastrongfoundationforadvancingthestudyofdifferentnovelcombinationregimens,"saidDr.EricRubin,vicepresidentandtherapeuticareahead,oncologyearly-stagedevelopment,MerckResearchLaboratories.

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